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Published on: January 24, 2014
A Pilot Study of the Normative Range of Overnight Urinary Free Cortisol Corrected for Creatinine in Children
Ole D Wolthers1, Sabine Mersmann2, Sanjeeva Dissanayake3
1Asthma and Allergy Clinic, Children's Clinic Randers, Dytmaersken 9, 8900, Randers, Denmark. akk.odws@dadlnet.dk.
Insights
This study establishes a preliminary normative range for urinary free cortisol corrected for creatinine (OUFCC) in prepubertal children with asthma. The findings provide a baseline for assessing inhaled corticosteroid bioactivity in this age group.
Area of Science:
- Pediatric Endocrinology
- Clinical Pharmacology
- Respiratory Medicine
Background:
- Urinary free cortisol corrected for creatinine (OUFCC) assesses inhaled corticosteroid bioactivity in children with asthma.
- Established paediatric normative ranges for OUFCC are lacking.
- This study aimed to define a preliminary OUFCC range in Tanner stage 1 children.
Purpose of the Study:
- To establish a preliminary normative range for urinary free cortisol corrected for creatinine (OUFCC).
- To assess OUFCC in children with mild asthma at Tanner stage 1.
Main Methods:
- Post hoc analysis of 26 Tanner stage 1 children (5-11 years) with mild asthma.
- Urine collection at the end of study periods (run-in, washout, treatment).
- Normative range derived using 95% prediction interval for geometric mean OUFCC.
Main Results:
- Analysis included 41 OUFCC values from 26 children.
- The geometric mean OUFCC was 9.0 nmol/mmol.
- The 95% prediction interval for OUFCC was 3.6 to 22.7 nmol/mmol.
Conclusions:
- A preliminary normative OUFCC range of 3.6 to 22.7 nmol/mmol was identified for Tanner stage 1 children.
- Larger studies in healthy children are needed to confirm these findings.
- Further research should explore OUFCC variations across developmental stages, age, gender, and race.
Background:
For more than a decade, urinary free cortisol corrected for creatinine (OUFCC) has been used to assess the systemic bioactivity of inhaled corticosteroids in children with asthma. Paediatric normative ranges, however, have not been established. The aim of the present study was to define a preliminary range for OUFCC in Tanner stage 1 children.
Methods:
A post hoc analysis was performed of 26 Tanner stage one children (aged 5-11 years) with mild asthma only requiring prn (pro re nata) treatment with short-acting β2-agonists, who participated in a 3-way cross-over knemometry study. The study comprised a run-in, two washout periods and three treatment periods (2 weeks each). Urine was collected at the end of each period. A normative range was derived using the 95% prediction interval for the geometric mean OUFCC, calculated from run-in and washout periods.
Results:
Twenty-six children contributed 41 OUFCC values. The geometric mean OUFCC was 9.0 nmol/mmol (95% PI: 3.6, 22.7 nmol/mmol).
Conclusions:
The OUFCC preliminary normative range was 3.6 to 22.7 nmol/mmol in Tanner stage one children. A larger study in healthy children is warranted to confirm these findings and to assess potential differences in OUFCC across developmental stages and age groups, and by gender and race.
Eudract Number:
2013-004719-32, CLINICALTRIALS.
Gov Identifier:
NCT02063139.
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